Effect of adding vildagliptin to insulin in haemodialysed patients with type 2 diabetes: The VILDDIAL study, a randomized, multicentre, prospective study.

AIM: To evaluate the effect of adding the dipeptidyl-peptidase-4 inhibitor vildagliptin to insulin on the glycaemic control of patients with type 2 diabetes undergoing haemodialysis. METHODS: Overall, 65 insulin-treated patients with type 2 diabetes undergoing haemodialysis (HbA1c: 7.3% ± 1.1%; age: 70.5 ± 8.5 years) were randomized (1:1) either to receive vildagliptin 50 mg/day in addition to insulin (vildagliptin-insulin group) or to pursue their usual insulin regimen (insulin-only group). Continuous glucose monitoring (CGM) was performed for 48 ± 6 hours at baseline and at week 12. The primary study endpoint was change from baseline in mean interstitial glucose using CGM. The secondary endpoints included other CGM variables and glucose control markers. RESULTS: After 12 weeks, a greater reduction in mean CGM glucose from baseline was observed in the vildagliptin-insulin group compared with the insulin-only group, although the between-treatment difference was not statistically significant (mean difference [CI 95%]: -0.96 mmol/L [-2.09; 0.18] vs. -0.29 mmol/L [-1.29; 0.76], P = 0.32). However, a significant decrease from baseline in HbA1c, glycated albumin and insulin daily doses was observed in the vildagliptin-insulin group versus the insulin-only group (-0.6% [-1.19; -0.1], P < 0.01), in the vildagliptin-insulin group versus no change in the insulin-only group (-130.6 µmol/L [-271; 10.7] vs. +36.2 µmol/L [-164.4; 236.9], P = 0.04 and - 5.9 IU/day [-1.8; 7.1] vs. +1.1 IU/day [-14.5; 16.6], P = 0.01, respectively). There was no significant difference in the percentage of time spent in hypoglycaemia using CGM, occurrence of severe hypoglycaemia or number of adverse events. CONCLUSION: In this study, vildagliptin added to insulin improved glycaemic control with an associated insulin-sparing effect in patients with type 2 diabetes undergoing haemodialysis and was well tolerated.

Continuous glucose monitoring in hemodialyzed patients with type 2 diabetes: a multicenter pilot study.

AIMS: Hemodialyzed patients with diabetes face an increased cardiovascular risk. Optimal glycemic control can reduce morbidity and mortality, but it is difficult to achieve because of the alternation between dialysis and non-dialysis periods. This study evaluated the contribution of continuous glucose monitoring (CGM) to the management of insulin regimen. METHODS: In this pilot prospective multicenter study, we performed CGM (Navigator®, Abbott, Rungis, France) for a total of 54 hours at baseline and for a 3-month follow-up period in a group of 28 hemodialyzed patients with type 2 diabetes treated by a basal-bolus detemir plus aspart insulin regimen. Insulin therapy was adapted to the CGM values. HbA1c and CGM parameters collected over the 3-month treatment period were compared using MANOVA for repeated measures. RESULTS: After 3 months, HbA1c significantly decreased from 8.4 ± 1.0% (65 ± 1 mmol/mol) to 7.6 ± 1.0% (60 ± 11 mmol/mol; p < 0.01). Similarly, mean CGM glucose values significantly decreased from 9.9 ± 1.9 to 8.9 ± 2.1 mmol/L (p = 0.05). The frequency of glucose values > 10 mmol/L significantly decreased from 41.3 ± 21.9% to 30.1 ± 22.4% (p < 0.05), without a significant increase in the frequency of glucose values < 3.3 mmol/L. Insulin requirements significantly increased from 70 ± 51 IU/d to 82 ± 77 IU/d (p < 0.001), without significant changes in body weight. CONCLUSIONS: CGM-adapted insulin regimen improves glycemic control without increasing hypoglycemic events in hemodialyzed diabetic patients. CGM could be a useful tool for the management of insulin therapy in these patients. These results need to be confirmed by long-term studies with larger sample sizes.

[Delayed measurement of PTH in patients with CKD: storage of the primary tube in the dialysis unit, which temperature? Which kind of tube?]. / Conservation du tube primaire sur le site de dialyse en vue du dosage différé de la PTH : quels tubes ? Quelle température ?

Parathyroid hormone (PTH) is measured in patients with chronic kidney disease (CKD) to evaluate the spread of secondary hyperparathyroidism and to identify renal osteodystrophy subtypes. An important intermethod variability that can significantly influence the clinical decision has been highlighted recently. Similarly, it is acknowledged that the preanalytical conditions are important to optimize the interpretation of a PTH level by comparison with the K/DOQI guidelines. Considering the frequent case of a dialysis patient in whom blood is handled in the evening and addressed to the clinical laboratory the next morning, we have evaluated the stability of the PTH concentration during a 18-hour period. We thus measured PTH with three automated assays in three kinds of tubes (plain tubes with a gel separator, EDTA tubes, EDTA+aprotinin tubes) which were either immediately centrifugated with a prompt freezing of the serum or plasma, or stored for 18hours at room temperature or at 4 degrees C. Our results demonstrate that, whatever the kind of tube, the PTH concentration is not altered by a 18-hour storage at 4 degrees C which is not the case at room temperature. Using a tube with a gel separator necessitates however to centrifugate the tube in the dialysis unit. On the other hand, the use of serum, by contrast with EDTA plasma, allows the measurement of other biological parameters including calcium, does not need that the tube is fully filled and, according to our results, reduces the intermethod variability. In conclusion, this study shows that the measurement of PTH may be delayed by 18hours if the primary tube is kept at 4 degrees C. Assuming that the primary tube is centrifugated but not opened in the dialysis unit, serum may be the sample of choice for the measurement of PTH in patients with CKD.

[Compliance and leaflet's reading, which link and which media? Results from a French population with chronic kidney disease]. / Observance et lecture des notices, quel lien et quels médias ? Résultats d'une population avec maladie rénale chronique.

Leaflets inside drug boxes are complex and often poorly understood. Patients consulting in nephrology are mostly old and often suffer from multiple comorbidities. As so, they are often subject to various contra-indications and drug interactions. This paper aims to evaluate if patients actually read leaflets or other medical information on others medias such as Internet and whether this could, potentially, interfere with their observance. Results showed that leaflets were read by 65.1% of patients, leading to 12% of withdrawal or not taking drugs. Furthermore, compliance to medical guidance was deemed e-read by 65.1% of patients, leading to 12% of withdrawal or not taken drugs. Furthermore, this study showed no clear profile for non-compliant patients. Even the youngest patients (under 50 years old) have had a good compliance, with not more withdrawal or not taking pills. Nonetheless, youngest patients used more often to consult alternative medias and did not read much of the leaflets' information. Patients who were reading leaflets however, tended to search further information on other medias. This situation would create new challenges in health care, as it seems that data available on new medias are not systematically validated or adapted to the needs of the patients.

Prognostic survival factors in elderly renal failure patients treated with peritoneal dialysis: a nine-year retrospective study.

BACKGROUND: Few studies specifically investigating elderly patients on peritoneal dialysis (PD) have been conducted and great uncertainty remains on the factors involved in the vital prognosis. The objective of this study was to describe our population of patients aged 75 years or older at the time PD was initiated and to study their survival in terms of the relevant nephro-geriatric criteria inventoried at the beginning of treatment. METHODS: We retrospectively analyzed the data of all the elderly patients that began first-line PD in our center between 1 January 1997 and 31 July 2006 (n = 112). RESULTS: Mean duration of survival on PD was 19.6 +/- 13.9 months; by the end of the study 87 patients had died and 7 had been transferred to hemodialysis. The Cox model multivariate analysis of survival allowed us to select 5 independent predictive variables that had a considerable impact on survival: absence of nephrologic care before dialysis, associated comorbidities (Charlson Comorbidity Index), loss of physical and/or mental autonomy (AGGIR group), and polymedication. Above and beyond the weight of these clinical variables, institutionalization or, more generally, social isolation was a determining factor for the duration of survival in PD. CONCLUSION: Any patient considered for peritoneal dialysis should be evaluated by a multidisciplinary team in collaboration with geriatric specialists for both the overall medical situation and the social and family environment.